A Facial Filler Needs a Dose of Patience

TO BANISH WRINKLES A patient being treated with Sculptra in the office of Dr. Z. Paul Lorenc, a plastic surgeon in Manhattan who uses it to fill in sunken cheeks, among other purposes.Credit
Fred R. Conrad/The New York Times

SCULPTRA, a long-lasting filler that has been used since 2004 to plump the cheeks of H.I.V.-positive patients with facial wasting, is finally having its cosmetic debut. In July, the Food and Drug Administration approved Sculptra Aesthetic — as the cosmetic version is named — for use to improve the appearance of nose-to-lip wrinkles (think Jack Nicholson’s Joker), horizontal chin wrinkles and so-called marionette lines that frame lips.

But that is not to say Sculptra is a new-to-the-ball debutante. Since 2004, Sculptra has been used off-label not only to tame stubborn skin folds but also to add volume to cheeks and temples withered by time. Now that Sculptra has been approved for some cosmetic uses, plastic surgeons and dermatologists are expecting a surge of interest.

Previously, little prevented a dermatologist or plastic surgeon from recommending Sculptra to a patient gaunt from exercise or distressed by hollow cheeks. In fact, last year, plastic surgeons and other doctors treated nearly 80,000 patients with Sculptra, up from 46,732 in 2005, according to the American Society of Plastic Surgeons.

Sculptra has already won over some doctors and patients. One advantage is its longevity; it can last up to two years once an optimal result is achieved, while alternative fillers including Restylane, Juvéderm and Evolence generally last a year or less. Another advantage is Sculptra’s ability to address broader depressions like sunken cheeks.

That said, the drawbacks of Sculptra include the need for several treatments in some cases to achieve a desired result, the need to massage the treated area for up to a week, and the risk of developing lumps beneath the skin.

Dr. Z. Paul Lorenc, a plastic surgeon in Manhattan who offers eight kinds of fillers, thinks of Sculptra primarily as a “volumizing agent.” Fillers tackle wrinkles or depressions by discretely plumping up tissue, Dr. Lorenc said. Sculptra, he said, “diffusely increases the volume of the area I’m injecting.”

Made of a synthetic material called Poly-L-lactic acid, Sculptra is injected deep into the tissue below the skin to spur a patient’s collagen growth gradually. Results — sometimes months in the making — look natural, a benefit touted by Sanofi-Aventis U.S., the company that makes Sculptra.

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FACE CHANGING A Sculptra patient in the Manhattan office of Dr. Z. Paul Lorenc.Credit
Fred R. Conrad/The New York Times

“What we bring to the market is natural and gradual replacement of lost collagen,” said Brent Ragans, the vice president of general therapeutics at Sanofi-Aventis U.S. “If you look at it from a consumer standpoint, the ability to look better over time, without people looking like something has been done” is desired.

Collagen renewal takes patience. “This is not a lunch-time filler,” said Dr. Karol A. Gutowski, chief of plastic surgery at NorthShore University HealthSystem in Illinois. “You don’t come in and boom, you’re ready to go to your cocktail party the next day.”

Often, multiple treatments, spaced four to six weeks apart, are necessary. Some lucky people respond to a single treatment, but two or three is more typical, most doctors interviewed for this article said.

At a time when many anti-aging fillers offer immediate results, that wait-and-see period tested the patience of Dr. Kevin S. Pinski, a dermatologist in Chicago, and that of his patients. “It’s a little bit of a tough sell,” said Dr. Pinski, who injected Sculptra in patients for roughly two years and no longer does.

Cost, too, can be an issue. Dr. Pinski, who is on the advisory boards for filler marketers Allergan and Medicis, then charged $1,000 for each vial of Sculptra. That results would last up to two years “was pretty darn good,” he said, and worth the final bill for some patients.

Other doctors nationwide charge $800 to $1,200 per Sculptra vial. At Dr. Lorenc’s office, a vial of Sculptra is $1,200, while Restylane and Juvéderm are $750 a syringe.

Side effects of Sculptra include tenderness and redness near the injection site. But what has caused the most concern is the occasional occurrence of small bumps that can be felt under the skin. Some bumps are visible. Doctors speculate that they are undispersed Sculptra or a result of not injecting deep enough.

Massaging after injection helps evenly distribute the product, some say, as does massaging injection sites for five minutes five times daily for five days after treatment. Dr. Gerald N. Bock, a dermatologist in Stockton, Calif., was so concerned about nodules that he discontinued his use of Sculptra. In a recent interview, he said, it’s a “nice filler” for broad areas like hollow cheeks and temples, but “you can certainly do that with other fillers like Restylane, Radiesse or Juvéderm.” They just won’t last as long, he said.

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A vial of Sculptra.Credit
Fred R. Conrad/The New York Times

In 2008, he called Sculptra a “time bomb” on his Web site because a few patients developed nodules, one 18 months after treatment. That blog post hasn’t stopped Sculptra representatives from wooing him. One once told him that several company representatives who received Sculptra treatments “have nodules they can feel but can’t see.”

Clinical trials found that 8.6 percent of patients who had been treated with Sculptra Aesthetic developed lumps. “That’s a bit high,” said Dr. Mark L. Jewell, a plastic surgeon in Eugene, Ore., and the organizer of the Physicians Coalition for Injectable Safety. “That to me is certainly higher than what I’ve seen with hyaluronic acid-type fillers.”

In a recent interview, Dr. Adriana Guana, the medical director for Sanofi-Aventis dermatology products, including Sculptra, emphasized that the patients who had complications were “still happy.” The lumps “were not bothersome, they were not serious, and they resolved spontaneously.”

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But patients who are horrified by their Sculptra lumps are not hard to find; their stories of woe are hotly discussed on cosmetic enhancement sites like RealSelf.com and MakeMeHeal.com.

Several doctors said the solution for a lump is either to wait months or years till it goes away on its own, or, Dr. Lorenc said, “you can excise it, that’s the real answer.” In contrast, after injections with hyaluronic acid fillers, “if you get a lump or bump or whatever, it can be injected with hyaluronidase” to dissolve it, said Dr. Alan Gold, the past president of American Society of Aesthetic Plastic Surgery. A doctor’s skill matters when it comes to all anti-aging injectables, and that is especially true for Sculptra. Dr. Lisa M. Donofrio, a dermatologist with four offices, including one in Manhattan, said she is upfront with candidates for Sculptra. “I can put it safely in you,” Dr. Donofrio said she tells them. “After that, it’s up to how your body forms collagen around this product.” (Dr. Donofrio has been paid to consult for the marketers of rival fillers Medicis, and Allergan; in 2004, Sanofi-Aventis.)

What’s more, off-label usage can be problematic because doctors can’t be educated for such indications by the maker of the injectable. “The company can’t even mention off-label uses,” said Dr. Brian M. Kinney, a clinical assistant professor of plastic surgery at University of Southern California. “If something became too enthusiastically implemented without a critical enough eye, the chances of problems greatly increase and we are not serving our patients.”

Several years ago, before Sculptra was approved for cosmetic use in the United States, Dr. Kinney was trained by Sanofi-Aventis in Europe to use Sculptra for facial wasting in H.I.V. patients. But as Dr. Guana of Sanofi-Aventis said, “what happens after the training is the physician practice and their own judgment.” Dr. Kinney began injecting Sculptra at his practice in Los Angeles after his return, and taught other stateside doctors how to best inject for aesthetic enhancement.

But the trouble, as Dr. Kinney sees it, is that when off-label uses of an injectable are not openly discussed there is a “risk of not wide enough a dissemination of pros and cons.” As of late July, Sanofi-Aventis can offer robust training for cosmetic indications for doctors, but some don’t feel that will necessarily change the landscape.

In the coming months, Dr. Robert Singer, a plastic surgeon in San Diego, foresees “a lot more people using it who aren’t appropriate providers” and he fears an uptick in injectors using Sculptra Aesthetic in inappropriate areas like in the lips and under-eye depressions. “I don’t want to say it doesn’t have its place,” said Dr. Singer, who has not injected much Sculptra in his practice. “I have friends who use it and like it. I think it needs to be judiciously used and I’d be concerned in superficial areas.”

A version of this article appears in print on September 24, 2009, on Page E1 of the New York edition with the headline: A Facial Filler Needs a Dose of Patience. Order Reprints|Today's Paper|Subscribe